Identity
- Trade Name
- evercare® Gynaecology set EUDAMED
- Device Name
- Surgical drapes, general purpose, sterile (Surgical drapes-others) EUDAMED
- Model / Reference
- 1253-01 EUDAMED1251-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129123647 EUDAMED06438129116823 EUDAMED
- Basic UDI-DI
- 6438129B0049HQ EUDAMED
- EMDN Code
- T020199 SURGICAL DRAPES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
evercare® Gynaecology set by OneMed Group Oy — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438129B0049HQ | Class I | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (2)
- EUDAMED a740d0e7-b532-48f7-ab9b-b040ace76600 61 fields · synced Jul 9, 2026
- EUDAMED 3a04cd65-c8df-4291-baf3-f9026154cc78 61 fields · synced May 19, 2026